Genetic toxicology testing, also known as genotoxicology, is the science of evaluating the ability of chemicals to cause damage to genetic material, such as DNA, and potentially lead to adverse health effects. Protheragen-ING Lab offers a comprehensive range of genotoxicity testing services to support the safety assessment of pharmaceuticals. By identifying genotoxic compounds early in the drug development process, we can minimize patient risk and ensure the safety of medicines, helping you make informed decisions about their safety profile. Our laboratories adhere to the highest standards of Good Laboratory Practice (GLP) regulations, ensuring the integrity and reliability of our data.
Common forms of genotoxicity
There are several common forms of genotoxicity that genetic toxicology assays aim to detect. These include:
- Gene Mutations: Gene mutations occur when changes in DNA sequences lead to alterations in the genetic code. These mutations can result in the production of abnormal proteins or the disruption of essential cellular processes.
- Chromosome Aberrations: Chromosome aberrations involve structural changes or numerical abnormalities in chromosomes. These alterations can lead to genetic instability and impair normal cellular function.
- Micronucleus Formation: Micronuclei are small, abnormal structures that form within cells as a result of DNA damage or chromosome breakage. The presence of micronuclei indicates genotoxic effects and potential chromosomal damage.
Comprehensive solutions for genotoxicity assessment
Below is an expanded list of common tests for genotoxicity that we can provide:
Genotoxicity Screening Tests
| Ames Test | It is a widely accepted bacterial mutagenicity assay that helps identify substances capable of inducing gene mutations. |
| Micro Ames Test | This test utilizes bacterial strains to assess the mutagenic potential of a substance. |
| Mini Ames Test | Similar to the Micro Ames Test, the Mini Ames Test is a modified version that requires a smaller amount of test substance. |
| In Vitro Micronucleus Assay | This assay is performed using cultured cells (such as CHO cells, human lymphocytes, and other cell lines) and determines the potential of a substance to induce chromosomal damage. |
| In Vitro Chromosome Aberration Test | In this test, cultured cells (such as CHO cells, human lymphocytes, etc.) are exposed to the test substance to assess its ability to induce structural chromosomal aberrations. |
GLP In Vitro Genetic Toxicity Assays
| Bacterial Mutation Test (Ames Test, OECD 471) | This test determines the mutagenic potential of a substance using bacterial strains. |
| Mammalian Cell Micronucleus Assay (OECD 487) | This assay evaluates the potential of a substance to induce micronuclei formation in mammalian cells. |
| Mammalian Chromosome Aberration Test (OECD 473) | This test assesses the potential of a substance to induce structural chromosomal aberrations in mammalian cells. |
| Mammalian Cell Gene Mutation Test (TK Gene, MLA, OECD 490) | This assay evaluates the mutagenic potential of a substance by assessing gene mutations in mammalian cells. |
| Mammalian Cell Gene Mutation Test (HPRT Gene, OECD 476) | This test specifically focuses on evaluating gene mutations in mammalian cells using the HPRT gene locus. |
| 3D Skin Comet Assay | This assay is designed to evaluate genotoxic potential by assessing DNA damage in skin cells. It provides valuable information on the potential dermal genotoxic effects of a substance. |
GLP In Vivo Genetic Toxicity Assays
| Rodent Micronucleus Test (OECD 474) | This test assesses the potential of a substance to induce micronuclei formation in the bone marrow cells of rodents. |
| Bone Marrow Chromosome Aberration Test (OECD 475) | This assay evaluates the potential of a substance to induce structural chromosomal aberrations in the bone marrow cells of rodents. |
| Mammalian Alkaline Comet Assay (OECD 489) | This test measures DNA damage in various tissues of rodents, providing valuable information on genotoxic potential. |
| Combined Comet/Micronucleus Assay | This assay combines the assessment of DNA damage using the Comet assay and micronucleus formation in rodent cells, providing a comprehensive evaluation of genotoxic potential. |
Building a genetically safe future together
Protheragen-ING Lab understands the importance of genetic safety in drug development. Our dedicated team of genetic toxicology scientists and experts is committed to providing accurate and reliable data to support your regulatory submissions and ensure the safety of your products.
By working with us, you can benefit from our state-of-the-art facilities, rigorous quality control, and adherence to GLP standards. We strive to provide timely results, expert consultation, and a collaborative approach to help you navigate the complexities of genetic toxicology.
Together, let's build a future where medicines are developed with genetic safety in mind, protecting patients and ensuring the well-being of people around the world.
Contact us today to learn more about our genotoxicity services and how we can help you assess the genetic safety of your medicines.